CBLL News & Events

CeriBell announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its Large Vessel Occlusion stroke detection monitor for patients in the hospital setting. The Breakthrough Device Designation for LVO Stroke builds on recent FDA 510(k) clearances for its next-generation Clarity algorithm to detect electrographic seizures in neonates and its proprietary delirium screening and monitoring solution, the company said.

CeriBell announced that the U.S. Food and Drug Administration, FDA, has granted 510(k) clearance for its proprietary delirium monitoring solution,1 the first and only FDA cleared delirium screening and monitoring device. This clearance further establishes the Ceribell System as an AI-powered brain monitoring platform technology, extending the benefits to a larger population of critically ill patients and providing additional information to assist in diagnosing patients at risk for both seizures and delirium.